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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030062
Receipt No. R000031891
Scientific Title A multi-center, cluster randomized controlled study comparing usual care and a multidisciplinary intervention such as the DELirium Team Approach program to manage delirium among hospitalized cancer patients
Date of disclosure of the study information 2017/12/11
Last modified on 2019/06/07

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Basic information
Public title A multi-center, cluster randomized controlled study comparing usual care and a multidisciplinary intervention such as the DELirium Team Approach program to manage delirium among hospitalized cancer patients
Acronym DELTA study
Scientific Title A multi-center, cluster randomized controlled study comparing usual care and a multidisciplinary intervention such as the DELirium Team Approach program to manage delirium among hospitalized cancer patients
Scientific Title:Acronym DELTA study
Region
Japan

Condition
Condition Malignacy
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Geriatrics Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Chest surgery Breast surgery
Nursing Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Delirium, defined as an acute disorder of attention and global cognitive function, is a common, serious, and potentially preventable cause of morbidity and mortality in hospitalized older persons. Primary prevention - preventing delirium before it develops - is the most effective strategy for reducing the incidence of this condition. The purpose of this multicenter, cluster randomized controlled study is to evaluate the effectiveness of multidisciplinary intervention in preventing the development of delirium and minimizing its severity in hospitalized cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence in events in medical safety such as falls, self-removal of drip infusion or drain tube, restraint
Key secondary outcomes Falls, Self-removal of drip infusion or drain tube, Restraint, Barthel Index, Level of nursing care needs, Antipsychotic drug use, Opioid use, Duration of hospital stay, Cost of medical care, Hospital readmission within 1 month after discharge, Mortality within 1 year after discharge

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Implementation of the DELTA program with six components: (1) education of health care providers, (2) screening of delirium, (3) planning for delirium care, (4) prevention of occurrence and worsening of delirium, (5) scheduled assessment of delirium symptoms or risk factors, and (6) management and treatment of delirium.
Interventions/Control_2 Usual care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
110 years-old >=
Gender Male and Female
Key inclusion criteria (1) Diagnosis of cancer at the primary site in health insurance claims
(2) Age >= 50
(3) Hospitalized patients in eligible wards
(4) Expected to live for more than 1 month
(5) Ability to communicate and write in Japanese
(6) Obtained informed consent from the patient or legally acceptable representative
Key exclusion criteria (1) Discharge within 24 hours after admission
(2) Severe mental disorder
(3) Patients incapable of completing this study as determined by the primary physician or investigator
(4) Expected to live for less than 1 month
(5) Readmission within length of registration
Target sample size 9600

Research contact person
Name of lead principal investigator
1st name Asao
Middle name
Last name Ogawa
Organization National Cancer Center
Division name Division of Psycho-Oncology, Exploratory Oncology Research&Clinical Trial Center
Zip code 277-8577
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577 Japan
TEL 04-7134-7013
Email asogawa@east.ncc.go.jp

Public contact
Name of contact person
1st name Kanno
Middle name
Last name Yusuke
Organization National Cancer Center
Division name Division of Psycho-Oncology, Exploratory Oncology Research&Clinical Trial Center
Zip code 277-8577
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577 Japan
TEL 04-7134-7013
Homepage URL
Email ykanno@east.ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization The Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577 Japan
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東札幌病院(北海道)、手稲渓仁会病院(北海道)、石巻赤十字病院(宮城県)、仙台医療センター(宮城県)、宮城県立がんセンター(宮城県)、がん・感染症センター都立駒込病院(東京都)、国立国際医療研究センター(東京都)、千葉医療センター(千葉県)、市立豊中病院(大阪府)、近畿中央胸部疾患センター(大阪府)、彩都友紘会病院(大阪府)、関西医科大学病院(大阪府)、和泉市立病院(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 9600
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 10 Month 05 Day
Date of IRB
2017 Year 10 Month 12 Day
Anticipated trial start date
2017 Year 12 Month 11 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 21 Day
Last modified on
2019 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031891

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/10/03 DELTA study(UMIN登録用20191002).xlsx


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